Novelion Therapeutics Announces Sentencing of Subsidiary Aegerion Pharmaceuticals
January 30 2018 - 5:51PM
Novelion Therapeutics
Inc. (NASDAQ:NVLN), a biopharmaceutical company
dedicated to developing new standards of care for individuals
living with rare metabolic diseases, today announced that
a U.S. District Court judge has sentenced Novelion subsidiary
Aegerion Pharmaceuticals. The sentence imposed by the Court, which
is part of Aegerion’s global settlement of investigations by the
U.S. Department of Justice (DOJ) and U.S. Securities and Exchange
Commission (SEC), is identical, in terms of the monetary impact to
the Company, to the recommendations contained in the plea agreement
filed with the court by Aegerion and DOJ as previously disclosed.
The Court decided not to impose a criminal fine and instead
established a restitution fund in the amount of $7.2 million, which
includes administration costs, to be paid in installments over
three years.
Aegerion’s global settlement consists of a
series of agreements, including the criminal plea agreement, which,
if all of the agreements are finally approved, would result in an
approximately $40.1 million aggregate penalty to be paid over three
years. This includes the restitution fund described above as well
as a civil penalty of $4.1 million to be paid to the SEC pursuant
to an SEC Judgment, and $28.8 million, including $2.7 million
designated for certain states, to be paid pursuant to the DOJ Civil
Settlement Agreement, which is subject to final approval by a U.S.
District Court Judge. As part of the global settlement,
Aegerion also has entered into a five-year corporate integrity
agreement (“CIA”) with the Department of Health and Human Services,
a three-year Deferred Prosecution Agreement (“DPA”) with the DOJ,
and a five-year Consent Decree for the Juxtapid REMS Program.
The CIA and DPA are in effect and the Consent Decree is subject to
approval by a U.S. District Court Judge.
Chairman of the Board of Directors Jason M.
Aryeh said, “We believe the global settlement of $40 million,
including the restitution fund, is in the best interest of our
stakeholders. The Court’s sentence is an important milestone that
allows us to move forward focusing on our business priorities,
namely reviewing our capital structure in an attempt to leverage
its flexibility, and providing important therapies to patients with
rare diseases. As a company, we are deeply committed to legal and
regulatory compliance. We have worked tirelessly to build a culture
of integrity and ethics under our new management team and Board of
Directors, in an effort to put legacy Aegerion challenges behind us
and focus intently on becoming a leader in rare disease
therapies.”
About Novelion Therapeutics
Novelion Therapeutics is a biopharmaceutical
company dedicated to developing new standards of care for
individuals living with rare metabolic diseases. Novelion has a
diversified commercial portfolio through its indirect subsidiary,
Aegerion Pharmaceuticals, Inc., which includes JUXTAPID® and
MYALEPT®. The company seeks to advance its portfolio of rare
disease therapies by investing in science and clinical
development.
Forward Looking Statements
Certain statements in this press release
constitute "forward-looking statements" within the meaning of
applicable laws and regulations and constitute "forward-looking
information" within the meaning of applicable securities
laws. Any statements contained herein which do not describe
historical facts, including statements regarding the final approval
of the DOJ settlement and statements about the investigations, the
settlement terms, and the company’s aspirations to become a leader
in rare disease therapies, are forward-looking statements which
involve risks and uncertainties that could cause actual results to
differ materially from those discussed in such forward-looking
statements. Such risks and uncertainties include, among others,
risks associated with the criminal plea agreement and other
settlement arrangements (including the government's recitation of
their assessment of the background of its case, the settlement
itself and publicity related to the settlement), the risk that the
investigation and the settlement will give rise to third party
demands, claims or litigation that could materially and adversely
impact our results of operations, including demands or claims by,
or litigation with, third party payers, healthcare providers, or
patients or investors, for matters related to the subject matter of
or disclosure in connection with the investigation or the
settlement, the likelihood that the investigation could lead to
potential investigations, claims or litigation by consumer
protection agencies or groups, or provide a basis for product
liability claims or litigation and the adverse effects the
investigation and settlement could have on Aegerion’s commercial
operations and contracts, along with those risks identified in our
filings with the U.S. Securities and Exchange Commission (the
“SEC”), including under the heading "Risk Factors" in our Annual
Report on Form 10-K filed on March 30, 2017, our Quarterly Report
on Form 10-Q filed on November 9, 2017, our Current Report on Form
8-K filed today, and subsequent filings (including our upcoming
Annual Report on Form 10-K), with the SEC, available on the SEC's
website at www.sec.gov. Any such risks and uncertainties could
materially and adversely affect our results of operations,
profitability and cash flows, which would, in turn, have a
significant and adverse impact on our stock price. We caution you
not to place undue reliance on any forward-looking statements,
which speak only as of the date they are made. Except as
required by law, we undertake no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
Investors and others should note that we
communicate with our investors and the public using our company
website www.novelion.com, including, but not limited to, company
disclosures, investor presentations and FAQs, SEC filings, press
releases, public conference calls transcripts and webcast
transcripts. The information that we post on these websites could
be deemed to be material information. As a result, we encourage
investors, the media and others interested to review the
information that we post there on a regular basis. The contents of
our website shall not be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended.
CONTACT:
Amanda Murphy, Director, Investor Relations
& Corporate CommunicationsNovelion
Therapeutics857-242-5024amanda.murphy@novelion.com
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